Celiac Disease Treatment TIMP-GLIA Wins Fast Track Status

TIMP-GLIA is a new nanoparticle-based celiac disease treatment. Will it work? The FDA has granted Fast track status to maker Cour Pharmaceuticals, so we may know sooner rather than later.

Caption: Photo: CC--Alosh Bennett

Celiac.com 02/05/2018 - TIMP-GLIA, a new nanoparticle-based celiac disease treatment currently under development by Cour Pharmaceuticals, has received Fast Track Designation from the US Food and Drug Administration (FDA). Phase 1 studies to assess the safety and tolerability of TIMP-GLIA are currently underway in the United States.

TIMP-GLIA works in part by encapsulating a component of wheat within a nanoparticle. The treatment has resulted in gluten tolerance in numerous animal models. By encasing components of gluten proteins in a nanoparticle, Cour is hoping that the gluten will remain unrecognized by the body's immune system, at least until immune tolerance can be generated through non-inflammatory antigen presentation.

The FDA created the fast track process to speed development, review and commercialization of drugs that target serious conditions and fill an unmet medical need. Fast Track Designation puts Cour in a "prime position to advance an innovative new approach for the treatment of Celiac Disease," said John J. Puisis, CEO of Cour Pharmaceuticals.

Cour is investigating TIMP-GLIA as part of an effort to reprogram the body's immune system so patients develop a tolerance to gluten as a non-threatening substance and ultimately to reduce or reverse celiac disease without the need for immune suppressing drugs. Cour's approach is designed to work by encasing a component of wheat in a nanoparticle, and introducing that particle into a celiac disease patient. If it works as designed, the gluten will remain unrecognized by the body's immune system until tolerance can be achieved through non-inflammatory antigen presentation.

The phase 1 clinical trial for TIMP-GLIA study is being conducted at centers in the United States. The objective of the study is to assess the safety and tolerability of TIMP-GLIA when administered intravenously (IV) as a single dose at ascending dose levels and as a repeat dose in subjects with celiac disease.

All in all, this is another of many bold and encouraging efforts to treat or cure celiac disease that have arisen in the last few years. Look for news of success or failure over then next few years.

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Guest Laura

Please ask yourself one question; Why are scientists trying to alter the human body rather than correcting the root cause of the problem which is modern dwarf wheat? There are studies showing that individuals with neither celiac disease nor diagnosed gluten sensitivity have "adverse reactions" to gluten. Diseases such as irritable bowel syndrome, fibromyalgia and other inflammatory diseases are believed to be worsened by exposure to gluten. Could it be that gastrointestinal diseases overall are perpetuated by the wheat proteins?

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Guest Jefferson

I do NOT trust any Pharmaceuticals to make anything "safe", all they care about is making money. Just take the time to read the "possible" side effects on any thing they make. Nor do I trust the FDA.

The list of safe and effective products made by pharmaceutical companies is likely long enough to fill a library. If you were born in the 20th century, you are likely alive and disease free precisely due to pharma products like vaccines. I don't know about you, but I'm pretty happy no having polio or measles, mumps, rubella, diphtheria, or any number of other potentially deadly or debilitating diseases that have been prevented by vaccines. So, there's that.

About Me

Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.